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Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).

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ClinicalTrials.gov Identifier: NCT03713190
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Stefano Del Prato, University of Pisa

Tracking Information
First Submitted Date  ICMJE July 18, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Changes in plasma Glucose level [ Time Frame: 2 hours ]
Because of their mechanism of action, SGLT-2 inhibitor efficacy to reduce plasma glucose level is highly dependent upon renal function. With GFR decreasing, glucose tubular load will decrease and less glucose will be reabsorbed because of SGLT2-inhibition.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).
Official Title  ICMJE A Phase II,Randomized,Cross-over,Double-blind, Placebo- Controlled,Single Center Study of the Effect of Empagliflozin a SGLT-2 Inhibitor,on Endogenous Glucose Production and Plasma Glucagon Levels in Patients With ESRD
Brief Summary A study of the effects of empagliflozin, a SGLT-2 inhibitor, on endogenous glucose production and plasma glucagon levels in patients with end-stage renal disease (ESRD)
Detailed Description The impact of SGLT-2 inhibition on endogenous glucose production and plasma glucagon levels will be compared measured in patients with ESRD.The secondary endpoints are the mean difference in plasma glucose, insulin, c-peptide, FFA,GH, epinephrine, norepinephrine, cortisol and blood pressure during the last hour of the experiment between empagliflozin versus placebo administration in patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE
  • Combination Product: Empagliflozin
    Sodium-glucose co-transporter 2 (SGLT2), a low-affinity, high-capacity member of an increasingly numerous family of co-transporters, is highly expressed in the proximal renal tubule, and account for the majority of the reabsorption of filtered glucose.
  • Drug: Placebo
    A substance without specific pharmacology principles
Study Arms  ICMJE
  • Active Comparator: Empagliflozin
    SGLT-2 inhibitor
    Intervention: Combination Product: Empagliflozin
  • Placebo Comparator: placebo
    A substance without specific pharmacology principles.
    Interventions:
    • Combination Product: Empagliflozin
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females
  2. Age = 30-70 years
  3. BMI< 40 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
  4. Normal Glucose Tolerance (HbA1c > 4.5 % and < 5.7%) or Type 2 diabetes (HbA1c >5.7 % and <10.0%)
  5. End Stage Renal Disease (GFR <15 ml/min/1.73 m 2 or hemodialysis)
  6. Subjects are capable of giving informed consent

Exclusion Criteria:

  1. Prednisone treatment
  2. Beta blocker or any medication that affects sympathetic/parasympathetic activity
  3. Known Empagliflozin Excipient Hypersensitivity
  4. Liver function enzymes higher more than two times the upper limit
  5. Ongoing urinary tract infection
  6. history of cancer of any type;
  7. cerebrovascular or symptomatic peripheral vascular disease;
  8. heart disease class III or IV NYHA;
  9. Type 1 Diabetes
  10. drug or alcohol abuse;
  11. life expectancy <3 yrs
  12. blood pressure >150/100 mmHg
  13. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter
  14. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment)
  15. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Giuseppe Daniele +3905099503 ext +3905099503 segreteriadiabetologia@ao-pisa.toscana.it
Contact: Stefano Del prato +3905099503 ext +3905099503 segreteriadiabetologia@ao-pisa.toscana.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713190
Other Study ID Numbers  ICMJE EMPA-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Stefano Del Prato, University of Pisa
Study Sponsor  ICMJE University of Pisa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefano Del prato University of Pisa
PRS Account University of Pisa
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP